Bedside Monitoring of Cerebral Energy State During the Peri-cardiac Arrest Period

NCT03095742 | Completed DMC

• 1 other identifier: S-20150173 HLP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In comatose patients resuscitated from out of hospital cardiac arrest (OHCA), neurological injuries remain the leading cause of death. The in-hospital mortality is reported at 30-50%, and the total mortality, although improved substantially over the last decade, remain to be significant, in most countries at up to 90%. An adequate blood pressure must be maintained in the post-cardiac arrest patient and helps to avoid further brain injury. The current trial addresses strategies for neuroprotection using a design of two different target blood pressure levels. "Normal MAP" (approximately 65 mmHg) vs. "high MAP" (approximately 75 mmHg). Markers measuring global cerebral ischemia caused by cardiac arrest and consecutive resuscitation, and reflecting the metabolic changes after successful resuscitation are urgently needed to enable a more personalized resuscitation and post resuscitation care. It is technically simple and feasible to place a microdialysis catheter in the jugular bulb and monitor biochemical variables related to cerebral energy metabolism bedside. The LP ratio obtained from microdialysis of cerebral venous blood may be a sensitive indicator of impending cerebral damage and might play a critical role in detecting the early responses of post resuscitation care. Aim of this study is to investigate the global cerebral metabolic changes during CA and post-resuscitation care.

Conditions

Cardiac Arrest; Neurological Complication; Post-Cardiorespiratory Arrest Coma

Keywords

Microdialysis; Cerebral metabolism; Cardiac arrest; Intravenous; Neurological prognosis

Outcome Measures

Primary Outcomes (1)

• LP ratio

  Analysis will compare the two target blood pressure groups with respect to lactate/pyruvate (LP) ratio.

  Peri-caridac arrest period - 72 hours

Secondary Outcomes (1)

• CPC

  72 hours

Study Arms (2)

Low MAP

PLACEBO COMPARATOR

Low mean arterial pressure. 30 patients were blindly randomized to normal range (MAP 65 mmHg) during the peri-cardiac arrest period.

Diagnostic Test: Low MAP

High MAP

ACTIVE COMPARATOR

High mean arterial pressure. 30 patients were blindly randomized to intervention group (MAP 75 mmHg) during the peri-cardiac arrest period.

Diagnostic Test: High MAP

Interventions

Low MAP DIAGNOSTIC_TEST

Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein

Also known as: Intravenous microdialysis

Low MAP

High MAP DIAGNOSTIC_TEST

Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein

Also known as: Intravenous microdialysis

High MAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Out-of-hospital cardiac arrest (OHCA)
• Presumed cardiac cause
• Unconsciousness (Glasgow Coma Score ≤8)
• Sustained return of spontaneous circulation (ROSC) (20 minutes of circulation)
• Target temperature management is indicated

You may not qualify if:

• Conscious patients
• Pregnancy
• OHCA of presumed non-cardiac cause
• Cardiac arrest after arrival in hospital
• Known bleeding diathesis
• Suspected or confirmed acute intracranial bleeding
• Suspected or confirmed acute stroke
• Temperature on admission \<30°C
• Unwitnessed asystole
• Persistent cardiogenic shock
• Known limitations in therapy
• Known disease making 180 day survival unlikely
• Known pre-arrest cerebral performance category 3 or 4
• \> 240 minutes from ROSC to randomization

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (1)

• Molstrom S, Nielsen TH, Nordstrom CH, Hassager C, Moller JE, Kjaergaard J, Moller S, Schmidt H, Toft P. Design paper of the "Blood pressure targets in post-resuscitation care and bedside monitoring of cerebral energy state: a randomized clinical trial". Trials. 2019 Jun 10;20(1):344. doi: 10.1186/s13063-019-3397-1.

  PMID: 31182135 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Simon Mølstrøm, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Interventions are considered emergency procedures and study blood pressure measurement using the study blood pressure modules should be commenced as soon as possible after sustained ROSC, screening and randomisation. Study target blood pressure will be blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Single center randomized trial with allocation of 60 comatose out-of-hospital cardiac arrest patients undergoing TTM, to normal or high blood pressure target during ICU stay. Secondary a descriptive prospective cohorte study, measuring LP ratio obtained by microdialysis (MD) of the cerebral venous outflow, during the peri-cardiac arrest period

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 30, 2017
• Study Start: September 1, 2017
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)